On December 20, 2021 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio" or the "Company"), a biopharmaceutical company pioneering Tissue Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported the closing of its initial public offering of 4,200,000 shares of its common stock at a public offering price of $5.00 per share, for gross proceeds of $21,000,000, before deducting underwriting discounts, commissions and offering expenses (Press release, Immix Biopharma, DEC 20, 2021, View Source [SID1234597457]). In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 630,000 shares of common stock at the initial public offering price, less the underwriting discount, to cover over-allotments.

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The shares began trading on the Nasdaq Capital Market on December 16, 2021 under the ticker symbol "IMMX."

ThinkEquity acted as sole book-running manager for the offering.

The Company intends to use the net proceeds from the offering to fund a planned IMX-110 Phase 2a clinical trial in soft tissue sarcoma and IMX-110 + tislelizumab Phase 1b combination trial, for IND-enabling studies for IMX-111 (colorectal cancer) and IMX-120 (inflammatory bowel disease), and for working capital and other general corporate purposes.

A registration statement on Form S-1 (file No. 333-259591) relating to the shares was filed with the Securities and Exchange Commission (the "SEC") and become effective on December 15, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC’s website, www.sec.gov, or by contacting ThinkEquity, 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 20, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that the company will present at two upcoming scientific meetings, the AACR (Free AACR Whitepaper) Special Conference: Targeting RAS, being held January 7-10, 2022 in Lake Buena Vista, Florida and the ASCO (Free ASCO Whitepaper) GI Cancers Symposium, being held January 20-22 in San Francisco, California (Press release, Kinnate Biopharma, DEC 20, 2021, View Source [SID1234597455]).

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"Since our founding, Kinnate has been driven by our mission to expand the availability of targeted therapies to all patients who may benefit from them," said Richard Williams, MBBS, Ph.D., Chief Medical Officer at Kinnate. "We are very pleased with the continued progress of both our RAF and FGFR inhibitor programs and look forward to sharing these updates with the oncology community at these upcoming meetings."

Details of the upcoming AACR (Free AACR Whitepaper) Special Conference: Targeting RAS presentation, which will be delivered by Paul Severson, Ph.D., Kinnate’s Senior Director of Translational Medicine and Bioinformatics, are as follows:

Abstract title: Real-World Clinico-Genomic Analysis of Patients with BRAF Mutated Solid Tumors Identifies BRAF Class II and III as a Significant Population of Unmet Need
Session: Poster Session A
Session date and time: Saturday, January 8, 2022, from 4:45PM -7:00PM ET
Additional information on the AACR (Free AACR Whitepaper) Special Conference: Targeting RAS is available through the conference website at: View Source

Details of the upcoming ASCO (Free ASCO Whitepaper) GI Cancers Symposium presentation, which will be delivered by Aleksandra Franovic, Ph.D., Senior Director of Translational Medicine at Kinnate, are as follows:

Abstract title: Activity of KIN-3248, a next-generation pan-FGFR inhibitor, against acquired FGFR-gatekeeper and molecular-brake drug resistance mutations
Session: Poster Session B
Session date and time: Friday, January 21, 2022, from 3:05PM – 4:35PM ET
Additional information on the ASCO (Free ASCO Whitepaper) GI Cancers Symposium is available through the conference website at: View Source

On December 20, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated therapeutics, reported preliminary Phase 2 results in patients with either advanced squamous non-small cell lung cancer (sqNSCLC) or head and neck squamous cell carcinoma (HNSCC), who were treated with CX-2029 – a CD71-directed conditionally activated antibody-drug conjugate (ADC) being co-developed by CytomX and AbbVie (Press release, CytomX Therapeutics, DEC 20, 2021, View Source [SID1234597454]).

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"We are pleased to report these first results from the ongoing Phase 2 expansion study of CX-2029, a novel ADC developed with the CytomX Probody Therapeutic platform. We are encouraged that the response rate in heavily-pretreated and unselected sqNSCLC patients at this recent data cut off is trending with our stated target of 20% and enrollment in this tumor type continues towards our goal of 25 efficacy-evaluable patients. No new safety signals were observed and we are also encouraged by the low discontinuation rate due to adverse events. These preliminary results corroborate our previous Phase 1 observations and open a potential sqNSCLC commercial opportunity in the growing post-checkpoint inhibitor setting where there are limited treatment options," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "We continue to work closely with our partner, AbbVie, and look forward to completing the expansion phase of the CX-2029 development program and providing further data updates in 2022."

As of the data cutoff on October 29, 2021, 23 patients with sqNSCLC and 29 patients with HNSCC had received at least one dose of CX-2029 at 3 mg/kg (safety population), of whom 16 sqNSCLC patients and 25 HNSCC patients had at least one post baseline assessment (efficacy-evaluable population), including, per protocol, 5 patients (2 sqNSCLC and 3 HNSCC) enrolled in the previously reported Part B (tumor biopsy cohorts). The median follow-up time was 3.8 months (range, 0.2-20.1). In the 16 efficacy evaluable patients with sqNSCLC, objective response rate (ORR) by local investigator was 18.8 percent, including two confirmed partial responses (PRs) and one unconfirmed PR that confirmed seven days after the data cutoff. Two of these responses were ongoing and the third had a response duration of 5.6 months. The disease control rate (DCR), which includes patients with a complete response, PR or stable disease, was 87.5 percent. In the 25 efficacy evaluable patients with HNSCC, there was one confirmed PR (ORR 4.0%) and a DCR of 56.0 percent, including one unconfirmed PR. Below is a summary table.

sqNSCLC HNSCC
Safety Evaluable Efficacy Evaluable Confirmed PR Safety Evaluable Efficacy Evaluable Confirmed PR
Part B 2 2 1 3 3 1
Part C 21 14 2* 26 22 0**
Total 23 16 3 29 25 1
ORR 18.8% 4.0%
*Includes one unconfirmed PR that confirmed after the data cutoff. **One unconfirmed PR was observed (will not confirm).

Safety analysis was conducted on all sqNSCLC and HNSCC patients who received at least one dose of CX-2029 at 3 mg/kg (N=52), either in Part B (N=5), or in the expansion cohorts (N=47). The median number of prior therapies in the metastatic setting was two (range, 1-5) for sqNSCLC and three (range, 1-9) for HNSCC. All patients with sqNSCLC had received prior platinum and prior checkpoint inhibition; in HNSCC, all but one patient received prior platinum and all but two, prior checkpoint inhibition.

The safety profile was consistent with previous Phase 1 observations, with no new safety signals identified. The most common treatment-related adverse events (TRAEs) in 10% or more of patients (All Grade, Grade 3) were anemia (78.8%, 67.3%), infusion related reactions (69.2%, 3.8%), fatigue (19.2%, 1.9%), and nausea (13.5%, 0.0%), and decreased neutrophil count (13.6%, 9.6% (plus one Grade 4 event 1.9%)). The most common reason for treatment discontinuation was disease progression (44.2%), three patients (5.8%) discontinued for a treatment-related adverse event (anemia; 2 Grade 2, 1 Grade 3). TRAEs leading to dose interruption or reduction were 40.4% and 34.6%, respectively. Thirteen patients, eight with sqNSCLC and five with HNSCC, were still on treatment as of the data cut off.

Conference Call & Webcast
CytomX management will host a conference call and a simultaneous webcast today at 5 p.m. ET (2 p.m. PT) to discuss these results. To join the conference call, please dial (877) 809-6037 (domestic) or (615) 247-0221 (international) and reference the conference ID 8065625. A live webcast of the call can be accessed via the Events and Presentations page of CytomX’s website at View Source A replay of the webcast will also be available for 30 days following the call.

About CX-2029
Co-developed by CytomX and AbbVie, CX-2029 is a conditionally activated antibody-drug conjugate (ADC) comprised of a CD71-directed humanized monoclonal antibody conjugated via a cleavable linker to the microtubule inhibitor, monomethyl auristatin E (MMAE), with a drug-to-antibody ratio (DAR) of 2. A key feature of CX-2029 is its masking peptide, which covers and blocks the cellular binding region of the antibody. Tethered to the antibody via a protease-cleavable linker, the masking peptide is designed to be removed in a protease-rich tumor microenvironment, enabling the then unmasked ADC to engage its target and deliver the toxic payload inside tumor cells. The goal is to have CX-2029 remain inert while in circulation, with the intent of limiting binding in healthy tissues until it is activated by tumor-associated proteases. CX-2029 is being evaluated as monotherapy in a Phase 2 expansion study (NCT03543813) designed to enroll patients in four cohorts; squamous non-small cell lung cancer, squamous head and neck cancer, esophageal and gastroesophageal junction cancers (both adenocarcinoma and squamous histologies), and diffuse large B-cell lymphoma.

On December 20, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT) ("Corcept"), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported the final results of its previously announced tender offer to purchase up to 10,000,000 shares of its common stock, par value $0.001 per share, at a price not greater than $23.75 nor less than $20.75 per share, in cash, less any applicable withholding taxes and without interest (the "Tender Offer"), which expired one minute after 11:59 p.m., New York City time, on December 15, 2021 (Press release, Corcept Therapeutics, DEC 20, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-final-results-previously [SID1234597453]).

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Based on the final count by Continental Stock Transfer & Trust Company, the depositary for the Tender Offer (the "Depositary"), 31,661,302 shares of Corcept’s common stock were validly tendered and not properly withdrawn at or below a purchase price of $23.75 per share.

In accordance with the terms and conditions of the Tender Offer, and based on the final count by the Depositary, Corcept has accepted for purchase 10,000,000 shares of common stock at a purchase price of $20.75 per share, for an aggregate cost of $207,500,000, excluding fees and expenses relating to the Tender Offer. The number of shares that Corcept has accepted for purchase in the Tender Offer represents approximately 9% of the total number of shares of common stock outstanding as of December 15, 2021. Corcept had approximately 105,933,592 shares of common stock outstanding following payment for the shares of common stock purchased in the Tender Offer.

Due to the oversubscription of the Tender Offer, based on the final count described above, Corcept accepted for purchase on a pro rata basis approximately 35% of the shares of common stock properly tendered and not properly withdrawn at the purchase price of $20.75 per share (other than "odd lot" holders, whose shares of common stock were purchased on a priority basis).

Shares of common stock not accepted for purchase will be returned promptly to stockholders. The Depositary will promptly pay for all of the shares of common stock accepted for purchase in accordance with the terms and conditions of the Tender Offer.

The sole dealer manager for the Tender Offer is Truist Securities, Inc. D.F. King is serving as the information agent for the Tender Offer and Continental Stock Transfer & Trust Company is serving as the depositary. Canaccord Genuity LLC is serving as a financial advisor. For all questions relating to the Tender Offer, please contact the information agent, D.F. King & Co., Inc. at [email protected] or call toll-free at 1 (800) 431-9646, or call the dealer manager, Truist Securities, Inc. at 1 (404) 926-5832.

Important Notice

This press release is for informational purposes only and is not an offer to buy or the solicitation of an offer to sell any securities of Corcept.

On December 20, 2021 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company), a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on molecularly targeted radiation (MTR), reported that the United States Food and Drug Administration (FDA) has approved Telix’s lead prostate cancer imaging product, Illuccix (Press release, Cardinal Health, DEC 20, 2021, View Source [SID1234597452]).

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Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in patients with prostate cancer with:

suspected metastasis who are candidates for initial definitive therapy;
suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
"The approval of Illuccix will give patients considerably improved access to PSMA-PET imaging, an advanced diagnostic tool that was recently included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines)1 for Prostate Cancer," said Dr. Oliver Sartor, Medical Director at Tulane Cancer Center. "With patient doses able to be prepared on-site or via commercial radiopharmacy networks, either via generator or cyclotron, Illuccix delivers flexible patient scheduling and on-demand access throughout the day."

Illuccix is the first commercially available FDA-approved product to enable wide accessibility to 68Ga- based PSMA-PET imaging for physicians and eligible patients across the United States. Illuccix can be prepared with 68Ga via either GE’s FASTlabTM cyclotrons or in nuclear pharmacies and healthcare centers across the country using Eckert & Ziegler’s GalliaPharm generator or IRE ELIT’s Galli Eo generator. This optionality along with a four-hour shelf life after radiolabeling with 68Ga, enables Illuccix to flexibly extend the reach of advanced PSMA-PET imaging to patients across the country.

"This product offers a level of flexibility and accessibility to healthcare professionals we really haven’t seen before in this class of products and may help us provide better patient experiences as a result," said Dr. Sartor.

With a distribution network encompassing more than 140 nuclear pharmacies through its agreements with Cardinal Health and PharmaLogic, Telix will be able to provide Illuccix to more than 85% of eligible PET imaging sites throughout the United States.

"This heralds a new era of patient and physician access to gallium-based PSMA-PET imaging and marks an important new stage for Telix as we bring our first commercial product to market in the United States," said Dr. Christian Behrenbruch, Managing Director and CEO at Telix. "Improved imaging can provide physicians with the insights to determine the most appropriate treatment pathway and give patients in the U.S. access to a specific and sensitive imaging tool for the detection of prostate cancer throughout the body."

About Illuccix

Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection.

68Ga gozetotide Injection is used for imaging prostate cancer with positron emission tomography (PET), and targets prostate specific membrane antigen (PSMA), a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Illuccix enables gozetotide (PSMA-11) to be labelled with the radionuclide 68Ga directly before injection by medical professionals. After preparing the radiopharmaceutical and injecting it into the patient, PSMA positive lesions are localized by PET imaging.

Illuccix has been approved by the U.S. Food and Drug Administration (FDA), and by the Australian Therapeutic Goods Administration (TGA). 2 Telix is also progressing marketing authorization applications for Illuccix in the European Union3, Canada4, and other jurisdictions around the globe.

Important Safety Information

WARNINGS AND PRECAUTIONS

Risk for Misdiagnosis
Image interpretation errors can occur with gallium Ga 68 gozetotide PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of gallium Ga 68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium Ga 68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non- malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Radiation Risks
Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers.

Advise patients to hydrate before and after administration and to void frequently after administration

ADVERSE REACTIONS

The safety of gallium Ga 68 gozetotide was evaluated in 960 patients, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). No serious adverse reactions were attributed to gallium Ga 68 gozetotide. The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of < 1%.

DRUG INTERACTIONS

Androgen deprivation therapy and other therapies targeting the androgen pathway

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

Please see full Prescribing Information at View Source

About Prostate Cancer in the United States

Prostate cancer is the second leading cancer in men in the United States after skin cancer, with nearly 250,000 cases estimated in 2021, a significantly higher incidence than either lung cancer (119,000 new cases) or bowel cancer (80,000 new cases). Prostate cancer was also the second leading cause of cancer death in U.S. men in 2020, and it is estimated that more than 34,000 men will die from their disease in 2021.5 More than 812,000 U.S. men were estimated to be living with prostate cancer in 2020.6 In 2021 the National Comprehensive Cancer Network Guidelines for prostate cancer were updated to include PSMA-PET imaging to be considered as an alternative to standard imaging of bone and soft tissue and for detection of unfavorable intermediate, high and very high risk as well as recurrent prostate cancer.